Role Objective:

To lead and direct a team of scientists in downstream process development for recombinant therapeutic proteins. The incumbent will oversee multiple candidate product projects, drive technology transfer to manufacturing facilities, ensure strict regulatory compliance.

KEY RESPONSIBILITIES
- Team Leadership: Lead, mentor, and supervise scientists executing downstream process development activities, fostering a culture of technical excellence and continuous learning.
- Project Oversight: Manage and oversee projects in the process development pipeline for candidate recombinant therapeutic proteins from conceptualization to execution.
- Process Engineering: Guide and execute scale-up, scale-down model validation, and comprehensive process characterization activities.
- Technology Transfer: Lead the seamless technology transfer of developed downstream processes to commercial manufacturing facilities.
- Documentation & Compliance: Author, review, and approve critical process development reports, technology transfer dossiers, and standard operating procedures (SOPs).




- Infrastructure & Resource Management: Maintain departmental infrastructure, plan equipment lifecycle, and contribute to optimal resource allocation and budgeting.
- Regulatory Alignment: Maintain an up-to-date, deep understanding of global regulatory and compliance guidelines (e.g., ICH, FDA, EMA), ensuring all development practices strictly adhere to these standards.

STAKEHOLDER INTERACTION

Type of Interaction: Internal
- Interaction with: Cross-functional teams including Upstream Process Development, Analytical Development (ADL), Quality Assurance (QA), Regulatory Affairs (RA), and Manufacturing Operations.
- Nature of Interaction: Collaboration on project requirements, project timelines alignment, troubleshooting development challenges, and coordinating technology transfer protocols.

Type of Interaction: External
- Interaction with: External vendors, technology partners, Contract Devel

📌 AGM/ DGM (Mumbai)
🏢 USV
📍 Mumbai